Miami Herald

Been vaccinated? Booster shots might be in your future

Scientists and public-health officials are debating whether booster shots should be like the original vaccines or modified to target variants.

- BY MICHAEL WILNER mwilner@mcclatchyd­c.com

Vaccines should provide protection against COVID-19 for at least nine months, but booster shots might become necessary after that, especially among the elderly, a top Food and Drug Administra­tion scientist said.

The projection comes as scientists and public-health officials debate which strategy to pursue on booster shots — whether vaccine manufactur­ers should produce booster shots that are essentiall­y the same as the original coronaviru­s vaccines or modify them to target a specific, mutant variant.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, told physicians on Tuesday that the agency will closely watch for waning immunity among vaccinated people with weaker immune systems nine to 12 months after they first received their doses.

“We’re believing that it’s probably going to last at least nine months, but we’re going to be checking this,” Marks said in a call hosted by the American Medical Associatio­n. “We need to be careful that in more immunocomp­ro

mised individual­s, particular­ly older individual­s — the oldest individual­s who are vaccinated — that we don’t see that drop off more quickly.”

“It is possible — we don’t know for sure — that somewhere at nine months, a year, we may need to have boosters,” Marks said. “But we’ll get a better sense of that, probably with each month, we’ll get more certainty about when that might be necessary.”

The current vaccines appear slightly less effective against some new variants that have emerged. At the same time, they appear effective enough that scientists consider them protective against both the variants and the original virus strain.

One White House official told McClatchy that the Biden administra­tion has remained intentiona­lly vague on its plans for the country’s excess supply of vaccines because they don’t know what works best for boosters yet.

The federal government has purchased roughly double the number of doses that will be necessary to vaccinate every American.

“It may just be by boosting with the same vaccine, you’ll get high enough titers that they would take care of these variants,” said Marks, referring to the concentrat­ion of antibodies in the blood provided by the vaccines. “There is something to be said for trying to keep it simple, because the more different types of vaccines that one has to manufactur­e, you basically take away from some of the capacity to manufactur­e as much vaccine.”

DETERMININ­G VACCINE DURABILITY

Dr. Kayvon Modjarrad, director of the Emerging Infectious Diseases Branch at the Walter

Reed Army Institute of Research, told McClatchy in a recent interview that scientists are not at the point where they are able to predict when immunity — whether naturally acquired after infection or through a vaccine — fades.

“When we look at animal studies, we look at antibody levels as one indicator,” Modjarrad

said. “They always decline with time. The question is how quickly do they decline and when do they get to a point that is below a threshold of antibody levels that you need to protect against disease. We haven’t quite defined that threshold yet.”

Scientists only know with confidence that a vaccine works for six months, for example, if they have six months of data proving it, Modjarrad said.

Pfizer and Moderna, which both use the same biological technology in

their vaccines and were first to complete their clinical trials, have recently published findings that show their vaccines remain over 90% effective after at least six months of data collection.

“All of this is good news, and we’ll find out — we’re looking at the unknown,” said Dr. Larry Corey, who has co-led the vaccine clinical trials for the COVID-19 Prevention Network under the National Institutes of Health. “The trials continue. They’ve been designed for two years. And the importance of those continued follow-ups is right in front of us.”

While only six months of data has been collected so far on the advanced, Phase III clinical-trial participan­ts, Corey noted that some volunteers who took part in the earliest phases of the trial in the spring of 2020 are now participat­ing in early trials on booster shots.

“They continue to be part of the exploratio­n of what’s needed — do we need to boost, when do we need to boost, and do we actually need to change the vaccine?” Corey said. “Maybe we don’t need to boost everybody, or if we do, we could just give another dose of the same vaccine.”

The Pfizer and Moderna vaccines, which use messenger RNA technology, already appear to differ in effectiven­ess against variants from the other vaccines — such as those made using viralvecto­r technology, from Johnson & Johnson and AstraZenec­a, and other protein-based vaccines.

“Each one is different. We already have data that they’re different, that it’s not going to be one size fits all,” Corey said on how the government is strategizi­ng for boosters. “The answer to me is different for each platform.”

As public-health officials and vaccine manufactur­ers debate whether to prepare boosters with the original vaccines or with modified vaccines, some worry that events might force their hands.

Dr. William Schaffner, who is an infectious-diseases expert at Vanderbilt University Medical Center and worked at the Centers for Disease Control and Prevention, said coronaviru­s vaccines might have to be more targeted geographic­ally than flu vaccines.

“The thing with influenza is, if you have dominant strains, they are pretty dominant over huge geographic areas. There isn’t any doubt,” Schaffner said. “At the moment, with COVID, it could become really very localized. They could have variants and strains that are dominant in Europe that are quite different than ours. That could happen in the Southern Hemisphere also.”

“There are further blank pages in our textbook on COVID, and we’re still writing those as we go along,” he added.

 ?? DANIEL A. VARELA dvarela@miamiheral­d.com ?? Hannah Sielk is vaccinated at Miami Dade College’s North Campus on March 6. The FDA says the protection provided by COVID-19 vaccines should last at least nine months.
DANIEL A. VARELA dvarela@miamiheral­d.com Hannah Sielk is vaccinated at Miami Dade College’s North Campus on March 6. The FDA says the protection provided by COVID-19 vaccines should last at least nine months.
 ?? DANIEL A. VARELA dvarela@miamiheral­d.co, file 2021 ?? The current vaccines appear slightly less effective against some variants. At the same time, they appear effective enough that scientists consider them protective against both the variants and the original virus strain.
DANIEL A. VARELA dvarela@miamiheral­d.co, file 2021 The current vaccines appear slightly less effective against some variants. At the same time, they appear effective enough that scientists consider them protective against both the variants and the original virus strain.

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